Requirements of Regulation (EC) no. 1223/2009

The sector of cosmetic products is regulated by Regulation (EC) no. 1223/2009, in force as of July 2013 in all Member States.

To market cosmetic products, companies should comply with a series of requirements provided for by the Regulation, including: a single and centralised notification for the whole EU via the Cosmetic Product Notification Portal (CPNP), a monitoring and vigilance system for side effects, the presence of a European responsible person, the preparation and continuous update of a dossier (Product Information File, PIF) reporting information on the cosmetic product, its toxicological profile and its safety.

The Regulation also specifies the rules for the importation of cosmetics from extra-EU countries as well as the responsibilities of the different subjects involved (manufacturer, importer, distributor).

Di Renzo Regulatory Affairs has a special unit dedicated to regulatory activities for cosmetic products, and can assist companies in the definition of the regulation requirements based on the company status. Moreover, we can support companies in all regulatory steps provided for cosmetic products, from the preparation of the PIF to the European notification and cosmetovigilance.